DIGESTIVE DISEASES RESEARCH DEVELOPMENT CENTERS
Release Date: April 26, 2001
RFA: RFA-DK-01-030 (November 27, 2006 (RFA-DK-06-018) -
This RFA has been reissued as RFA-DK-06-018.
National Institute of Diabetes and Digestive and Kidney Diseases
Letter of Intent Receipt Date: September 26, 2001
Application Receipt Date: October 29, 2001
PURPOSE
The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
invites applications for Digestive Diseases Research Development Centers
(DDRDCs). These Research Development Centers will support shared research
resources, or cores, to be used by groups of NIDDK-funded investigators pursuing
research that can be enhanced by the use of those shared resources, but who do
not currently have access to a Silvio O. Conte Digestive Diseases Research Core
Center. DDRDCs will enhance capabilities for conducting basic, clinical, and/or
translational digestive diseases research relevant to the mission of the
Division of Digestive Diseases and Nutrition (DDDN), NIDDK. The major purpose
of this initiative is to increase the availability of core resources, with the
goal of fostering research, collaborations, and new directions in digestive and
liver disease research.
HEALTHY PEOPLE 2010
The Public Health Service (PHS) is committed to achieving the health promotion
and disease prevention objectives of "Healthy People 2010," a PHS-led national
activity for setting priority areas. Potential applicants may obtain a copy of
"Healthy People 2010" at http://www.health.gov/healthypeople/.
ELIGIBILITY REQUIREMENTS
Applications may be submitted by domestic, for-profit and non-profit
organizations, public and private, such as universities, colleges, hospitals,
laboratories, units of State and local governments, and eligible agencies of the
Federal government. Foreign institutions are not eligible for resource-related
research project (R24) grants. Racial/ethnic minority individuals, women, and
persons with disabilities are encouraged to apply as DDRDC Directors and/or
core directors.
Each application for a DDRDC must propose to serve a minimum of six NIH Research
Project (R01), Exploratory/Development (R21), MERIT (R37), and/or Program
Project (P01) grants, with no less than 10 grant-years collectively remaining in
the council-recommended project periods of those grants at the time of the start
date for the DDRDC. A minimum of three of these grants must be supported by the
NIDDK. This cohort of funded grants will be known collectively as the
‘base grants’ for the DDRDC. Every grant counted in the base must have more than
one year remaining in the council-recommended project period at the requested
start date for the DDRDC. No other mechanism or source of support will be
considered in determining eligibility. While only three NIDDK grants are
required, it is anticipated that the composition of the base grant portfolio
will strongly influence funding decisions by the NIDDK.
Only one DDRDC will be awarded to any single applicant organization. Principal
Investigators of the base grants, however, may be located at several affiliated,
or closely aligned, institutions provided a clear plan of operation is provided
describing administration structure and current interactions among the
investigators. Each NIDDK base grant may only serve that purpose for one DDRDC.
If well justified, supported core activities and core-related research may be
located at sites and institutions other than that/those of the base grants and
the DDRDC. This could be justified, for example, when the applicant institution
is located in close proximity to a research institution with a well-established
gnotobiotic animal facility, when it would not be logical or cost effective to
duplicate the facility at the DDRDC institution.
Each DDRDC will support one to three cores. Each core must be used by at least
three of the base grants, and, in general, should serve as many base grants
as possible.
Direct costs requested on each DDRDC application may not exceed 25 percent of
the annual direct costs awarded to the base grants at the anticipated start date
for the DDRDC. Maximum allowable direct costs may not exceed $350,000 per year.
MECHANISM OF SUPPORT
DDRDCs will be supported by the resource-related research project grant (R24)
mechanism. Each of the cores comprising a DDRDC should provide services,
equipment, and/or other research resources to the base grants. Research related
to the cores, in turn, will enhance the capabilities of those cores. The
coordinated use of shared resources should increase the efficiency of digestive
diseases research, facilitate the use of new technologies and the pursuit of new
lines of investigation, and promote interdisciplinary and collaborative research.
Up to five years of support may be requested.
DDRDCs will be eligible for one competing renewal, making 10 years the maximum
support period for a DDRDC. Former DDRDCs may apply, after a hiatus of at least
two years, and in response to a Request for Applications, for a new DDRDC.
Alternatively, former DDRDC awardees may wish to compete for a Silvio O. Conte
Digestive Diseases Research Core Center (P30) grant. The latter compete for
funding in response to periodic Requests for Applications.
This RFA is a one-time solicitation. The anticipated award date is
December, 2002.
FUNDS AVAILABLE
The NIDDK will commit $1.5 million in FY 2003 to fund 3 to 5 new R24 grants in
response to this RFA. An applicant may request a project period of up to 5 years
and a budget for direct costs of up to $350,000 per year, excluding facilities
and administrative (F&A) costs on consortium arrangements. Although the
financial plans of the NIDDK provide support for this program, awards pursuant
to this RFA are contingent upon the availability of funds and the receipt of a
sufficient number of applications of outstanding scientific and technical merit.
RESEARCH OBJECTIVES
Background
The NIDDK recognizes that a critical mass of funded investigators is needed to
provide the research base for a large core grant, such as a Silvio O. Conte
Digestive Diseases Research Core Center, but that many sites around the country
support smaller groups of NIDDK-funded investigators whose research would be
enhanced, and could be extended, by the existence of shared core facilities. The
DDRDC award is designed to allow groups of investigators already engaged in
common thematic areas of digestive diseases research to benefit from shared
research resources on a smaller scale than our P30 centers program. The use of
such shared resources is expected to increase efficiency and cost-effectiveness
by eliminating unnecessary duplication of effort and by supporting resources
(e.g., costly equipment) that might be needed by, but not fully utilized by, any
one research grant or investigator.
Objectives and Scope
The primary purpose of each DDRDC is to support shared research resources to
enhance the capabilities of NIDDK-supported investigators who are pursuing
research in areas of interest to the DDDN. A DDRDC will support cores and
core-related research representing shared research resources and activities that
can include services (e.g., cell isolations, patient recruitment, statistical
support), equipment (e.g., confocal microscope, scanning electron microscope),
or other resources (e.g., use of transgenic facilities, access to batch
preparation of reagents, clinical research resources). The DDRDC must benefit
the base grants that it serves and should increase efficiency, promote new
research directions, and foster interactions and collaborations among the base
grant researchers.
Cores can also promote new research directions and innovative uses of technology
by providing access to techniques, equipment, services, and expertise that might
not otherwise be available. DDRDC cores may not be used to fund pilot projects,
per se, but can help investigators validate novel hypotheses and generate
sufficient preliminary data for the submission of a research project grant. It
is anticipated that the proper use and management of the cores in the DDRDC will
promote interactions, collaborations, and new projects that will in turn advance
the field of digestive diseases research.
Cores may also be used judiciously by investigators not directly supported by
base grants, as long as the core usage provides opportunities for new
investigators, for minority investigators, and for investigators wishing to
become involved in the research base of the DDRDC.
The proposed Director of the DDRDC must have a demonstrated ability to organize,
administer, and direct the DDRDC, must be the Principal Investigator on one of
the base grants, and may also serve as the head of a core.
Research Topics
The following are examples of the research supported by the NIDDK which would be
eligible to apply for DDRDCs: pediatric liver disease, pediatric
gastroenterology, celiac disease, inflammatory bowel disease, motility
disorders/irritable bowel syndrome, diarrheal diseases, pancreatitis/pancreatic
disease, peptic ulcer disease/Helicobacter pylori, gene therapy of liver or
digestive disorders, gastroesophageal reflux disease/Barrett’s esophagus, and
gastrointestinal aspects of AIDS. This list is neither inclusive, nor exclusive,
and consultation with program staff is advisable to determine the programmatic
suitability of a research focus for a DDRDC.
INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS
It is the policy of the NIH that women and members of minority groups and their
sub-populations must be included in all NIH-supported biomedical and behavioral
research projects involving human subjects, unless a clear and compelling
rationale and justification are provided indicating that inclusion is
inappropriate with respect to the health of the subjects or the purpose of the
research. This policy results from the NIH Revitalization Act of 1993 (Section
492B of Public Law 103-43).
All investigators proposing research involving human subjects should read the
UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in
Clinical Research," published in the NIH Guide for Grants and Contracts on August
2, 2000 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html), a
complete copy of the updated Guidelines are available at
http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm: The
revisions relate to NIH defined Phase III clinical trials and require: a) all
applications or proposals and/or protocols to provide a description of plans to
conduct analyses, as appropriate, to address differences by sex/gender and/or
racial/ethnic groups, including subgroups if applicable, and b) all
investigators to report accrual, and to conduct and report analyses, as
appropriate, by sex/gender and/or racial/ethnic group differences.
INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS
It is the policy of NIH that children (i.e., individuals under the age of 21)
must be included in all human subjects research, conducted or supported by the
NIH, unless there are scientific and ethical reasons not to include them. This
policy applies to all initial (Type 1) applications submitted for receipt dates
after October 1, 1998.
All investigators proposing research involving human subjects should read the
“NIH Policy and Guidelines on the Inclusion of Children as Participants in
Research Involving Human Subjects” that was published in the NIH Guide for
Grants and Contracts, March 6, 1998, and is available at the following URL
address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html.
URLS IN NIH GRANT APPLICATIONS OR APPENDICES
All applications and proposals for NIH funding must be self-contained. Internet
addresses (URLs) should not be used to provide information necessary to the
review because reviewers are under no obligation to view the Internet sites.
Reviewers are cautioned that their anonymity may be compromised when they
directly access an Internet site.
LETTER OF INTENT
Prospective applicants are asked to submit, by September 26, 2001, a letter of
intent that includes a descriptive title of the proposed research, the name,
address, and telephone number of the Principal Investigator, the identities of
other key personnel and participating institutions, and the number and title of
this RFA-DK-01-030.
Although a letter of intent is not required, is not binding, and does not enter
into the review of a subsequent application, the information that it contains
allows NIDDK staff to estimate the potential review workload and plan the review.
The letter of intent is to be sent or e-mailed to:
Chief, Review Branch
Division of Extramural Activities, NIDDK
6707 Democracy Boulevard, Rm. 752 MSC 5452
Bethesda, MD 20892-5452
(for express/courier service: Bethesda, MD 20817)
Telephone: (301) 594-8885
FAX: (301) 480-3505
E-mail: fc15y@nih.gov
APPLICATION PROCEDURES
Applicants are strongly encouraged to call NIDDK program staff with any
questions regarding the responsiveness of their proposed application to the
goals of this RFA.
Applications are to be submitted on the grant application form PHS 398 (rev.
4/98) and will be accepted only on or before the receipt date for this RFA,
October 29, 2001. Application kits are available at most institutional offices
of sponsored research and may be obtained from the Division of Extramural
Outreach and Information Resources, National Institutes of Health, 6701
Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone (301) 435-0714,
fax: (301) 480-0525 Email: . The application is also
available at http://grants.nih.gov/grants/funding/phs398/phs398.html
The title and number of this RFA, DK-01-030, must be typed in Section 2 on the
face page of the application.
The DDRDCs are intended to enhance the capabilities of NIDDK-supported
investigators to pursue digestive diseases research. The manner in which the
proposed DDRDC will do this must be evident from the information provided in the
application. The following sections should replace the Specific Aims,
Background and Significance, Preliminary Studies/Progress Report, and the
Research Design and Methods sections of the traditional Research Plan in form
PHS 398 (Rev. 4/98):
o General Description of the Base Grants. Each base grant should be described
in no more than two pages, one page is preferred. The following must be provided
for each base grant: the grant number, title, name of the PI, grantee
organization, the project period end date, and the direct cost budget for the
year on which the budget of the DDRDC application is based. In addition, the
single page per grant must include a description providing an overview of the
research goals and approaches used in the grant and the manner in which the
DDRDC award will enhance, complement, or expedite the research activities of the
research supported by the base grant.
In addition, the specific ways in which the DDRDC will increase efficiency,
promote new research directions, and foster collaborations should be described
in the context of all the base grants in another section, not to exceed 4 pages.
o Core Descriptions. These should not exceed 5 pages for any one core and
should detail the purpose of the core, any anticipated core-related research,
including the manner in which the research is expected to enhance the
capabilities of the core, and must clearly delineate the space, facilities,
resources, services, technical and professional expertise and support that the
core will provide. If a fee-for-service is anticipated, this must be described.
The specific manner in which each core will relate to base grants must also be
described as well as how each base grant will benefit from the core. For each
core, describe the degree of use by the relevant base grants, and the
investigators supported by the base grants, keeping in mind that each core must
be used by at least three of the base grants. It is not sufficient for a single
investigator, holding three grants, to be the sole user of a core. Also,
describe any anticipated use of the core facility by non-base grant
investigators and the rationale for and extent of such use, if appropriate.
o Operational Plan. This should not exceed the equivalent of 2 pages per core,
and may be included as a sub-section of each of the core descriptions, or as an
overarching plan for the operation of the DDRDC. The operational plan should
describe arrangements required to manage the DDRDC, including the manner in
which priority for core access and use is determined, the operational and
administrative role of the director of each core, and plans for upgrades,
enhancements, and modifications of core offerings as well as the plans for
quality control. Any committee structure developed for managing the center
should be described here, also.
In exceptional circumstances, a core may be located at a site other than that of
the DDRDC. For those applications proposing an offsite core, clear
justification for this arrangement must be included.
Budget
The maximum direct costs requested may not exceed 25% of the direct costs for
the base grants for the year in which the DDRDC would begin, up to a maximum of
$350,000 per year in direct costs. The requested budget should include the
costs of travel for the DDRDC Director to attend the yearly Digestive Diseases
Centers Directors’ meeting in the budget.
Other
The RFA label available in the PHS 398 (rev. 4/98) application form must be
affixed to the bottom of the face page of the application. Failure to use this
label could result in delayed processing of the application such that it may not
reach the review committee in time for review. In addition, the title of this
RFA (Digestive Diseases Research Development Centers) and number (DK-01-030)
must be typed on line 2 of the face page of the application form and the YES box
must be marked.
Submit a signed, typewritten original of the application, including the
Checklist and appendices, and three signed photocopies, in one package to:
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040 - MSC 7710
Bethesda, MD 20892-7710
Bethesda, MD 20817 (for express/courier service)
At time of submission, two additional copies of the application and appendices
must be sent to:
Chief, Review Branch
Division of Extramural Activities, NIDDK
6707 Democracy Boulevard, Rm. 752 MSC 5452
Bethesda, MD 20892-5452
(for express/courier service: Bethesda, MD 20817)
Applications must be received by October 29, 2001. If an application is
received after that date, it will be returned to the applicant without review.
The Center for Scientific Review (CSR) will not accept any application in
response to this RFA that is essentially the same as one currently pending
initial review, unless the applicant withdraws the pending application. The CSR
also will not accept any application that is essentially the same as one already
reviewed. This does not preclude the submission of substantial revisions of
applications previously reviewed.
REVIEW CONSIDERATIONS
Upon receipt, applications will be reviewed for completeness by the CSR and
responsiveness by the NIDDK. Incomplete and/or non-responsive applications will
be returned to the applicant without further consideration.
Applications that are complete and responsive to this RFA will be evaluated for
scientific and technical merit by an appropriate peer review group, convened by
the NIDDK, in accordance with the review criteria stated below. As part of the
initial merit review, all applications will receive a written critique and
undergo a process in which only those applications deemed to have the highest
scientific merit, generally the top half of the applications under review, will
be discussed, assigned a priority score, and receive a second level review by
the National Diabetes and Digestive and Kidney Diseases Advisory Council.
Review Criteria
Criteria for scientific/technical review of DDRDC grant applications will
include the following:
o Approach: Is the research development center grant approach appropriate?
The need for and suitability of the DDRDC approach will be assessed as well as
whether this support will significantly enhance the capabilities of base grant
investigators to pursue digestive diseases research. In addition, the likelihood
that the DDRDC will increase efficiency, promote new research directions,
facilitate interactions and collaborations among DK-funded investigators, and
prove cost-effective will be evaluated.
o Innovation: Is it likely that the proposed resources, in support of the base
grants, will lead to fundamental advances within the field, to new discoveries,
and/or to new technological, clinical, or scientific developments? The overall
quality, scientific merit, and suitability of the activities to be supported as
well as the likelihood that the cores will significantly enhance the research of
the individual investigators will be evaluated.
o Investigators: The capability and scientific credentials of the Director of
the DDRDC, the core directors, and other participating investigators will
be assessed.
o Significance: Will the existence of the DDRDC grant significantly enhance
the funded research, provide opportunities not otherwise available to the
investigators, represent an appropriate cost savings/cost sharing advantage, and
stimulate the development of new approaches? Are the operational plans and core
structure appropriate? Is the organizational and administrative structure,
oversight, and contingency plans for the management of the DDRDC adequate?
o Environment: What is the nature and level of resource commitment from the
applicant institution and from any other participating institutions? Do the
proposed cores appear to complement or to enhance what is already available at
the institution?
The initial review group will also examine: the appropriateness of proposed
project budget and duration. For applications requesting support for cores
dealing with human subjects or animals, the initial review group will examine:
the adequacy of plans to include both genders, minorities and their subgroups,
and children, plans for the recruitment and retention of subjects, the
provisions for the protection of human and animal subjects, and the safety of
the research environment.
The initial review group will make an overall recommendation to score (by
assigning a priority score) or not to score the entire DDRDC application. Under
some circumstances, it may be appropriate for the initial review group to
recommend that one or more core(s) not be recommended for further consideration.
Schedule
Letter of Intent Receipt Date: September 26, 2001
Application Receipt Date: October 29, 2001
Peer Review Date: March, 2002
Council Review: May, 2002
Earliest Anticipated Start Date: December, 2002
AWARD CRITERIA
Award criteria that will be used to make award decisions include:
o Scientific merit as determined by peer review,
o Availability of funds,
o Programmatic priorities,
o Geographic distribution.
INQUIRIES
Inquiries concerning this RFA are encouraged. The opportunity to clarify any
issues or questions from potential applicants is welcome.
Direct inquiries regarding programmatic or review issues to:
Judith Podskalny, Ph.D.
Division of Digestive Diseases and Nutrition
NIDDK
6707 Democracy Boulevard, Rm. 667 MSC 5450
Bethesda, MD 20892-5450
Telephone: (301) 594-8876
FAX: (301) 480-8300
E-mail: jp53s@nih.gov
Direct inquiries regarding fiscal matters to:
Teresa Farris
Division of Extramural Activities
NIDDK
6707 Democracy Boulevard, Rm. 728 MSC 5456
Bethesda, MD 20892-5456
Telephone: (301) 594-7682
FAX: (301) 480-3504
E-mail: tf102y@nih.gov
AUTHORITY AND REGULATIONS
This program is described in the Catalog of Federal Domestic Assistance No.
93.848. Awards are under authorization of the Public Health Service Act, Title
IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and
285) and administered under NIH grants policies and Federal Regulations 42 CFR
52 and 45 CFR Parts 74 and 92. This program is not subject to the
intergovernmental review requirements of Executive Order 12372 or Health Systems
Agency review.
The PHS strongly encourages all grant and contract recipients to provide a
smoke-free workplace and promote the non-use of all tobacco products. In
addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in
certain facilities (or in some cases, any portion of a facility) in which
regular or routine education, library, day care, health care or early childhood
development services are provided to children. This is consistent with the PHS
mission to protect and advance the physical and mental health of the
American people.